Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol

NCT00853632 | Completed Results FDA Device

• 1 other identifier: 2006-05
• Study Type: interventional
• Target: 329
• Locations: 4 countries
• Sites: 15

Brief Summary

The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards® PERIMOUNT Magna Mitral Valves in patients undergoing mitral valve replacement with or without concomitant procedures requiring cardiopulmonary bypass.

Conditions

Coronary Artery Disease; Mitral Valve Regurgitation; Mitral Valve Incompetence; Heart Failure

Keywords

Mitral valve; pericardial bioprostheses; PERIMOUNT; bovine pericardial leaflets; mitral valve replacement; mitral valve regurgitation; Heart valve disease

Outcome Measures

Primary Outcomes (2)

• Subject's Rate of Objective Performance Criteria Per ISO 5840-2005 - Total Number of Late Adverse Events (by Category) Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort

  A linearized rate percentage is calculated by the following equation: \[(Total number of late adverse events in each category/total number of late patient years) x 100\]. Late adverse events are events that occur ≥ 31 days post-implant through each subject's last follow-up visit or contact. Late patient years are calculated by totaling the amount of time the valve is implanted in the patient while participating in the trial and the count begins at ≥ 31 days post-implant through all subject's last follow-up visit or contact.

  Events occurring ≥ 31 days and up through 8 years post-implant

• Primary Effectiveness Endpoints

  The primary effectiveness endpoint will be the percentage of subjects in NYHA functional classification I or II at 8 years post-implant.

  8 years post-implant

Secondary Outcomes (19)

• Percent of Early Adverse Events

  Events occurring within 30 days of procedure

• Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time

  6 months post-implant

• Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort

  Events occurring ≥ 31 days and up through 8 years post-implant

• Subject's Average Mean Gradient Measurement

  Baseline and 8 years post-implant

• Subject's Average Peak Gradient Measurement

  Baseline and 8 years post-implant

Study Arms (1)

Device - CEP Mitral Valve

OTHER

Device: CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES

Interventions

CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES DEVICE

Mitral valve replacement

Also known as: Magna Mitral 7000/7000TFX, Magna Mitral Ease 7200TFX, 7300/7300TFX

Device - CEP Mitral Valve

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient requires, as indicated in the preoperative evaluation, a replacement mitral valve.
• The patient has signed and dated the subject informed consent form prior to surgery.
• The patient is expected to survive the surgery and be discharged.
• The patient is geographically stable and agrees to attend follow-up assessments.
• The patient is 18 years or older.

You may not qualify if:

• The patient has any known non-cardiac life-threatening disease, which will limit the patient's life expectancy below 1 year.
• The patient presents with active endocarditis within the last 3 months.
• The patient is pregnant or lactating.
• The patient is an intravenous drug abuser.
• The patient is currently a prison inmate.
• The patient is currently participating in a study of an investigational drug or device.
• The patient requires replacement of a native or prosthetic tricuspid or pulmonic valve.
• The patient requires replacement of a native or prosthetic aortic valve with a prosthesis other than a commercially available Carpentier-Edwards PERIMOUNT Valve (i.e. models 2700, 2700TFX, 2800, 2800TFX, 2900, 3000, 3000TFX, 3300TFX)\*.
• The patient was previously enrolled in the study.
• The patient has had prior aortic, tricuspid and/or pulmonary valve surgery, which included implantation of a bioprosthetic valve or mechanical valve that will remain in situ.

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (15)

Dignity Health Research Institute

Sacramento, California, 95816, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Northwestern University Hospital

Chicago, Illinois, 60611, United States

Location

University of Iowa Hospital & Clinics

Iowa City, Iowa, 52242, United States

Location

Iowa Heart Medical Center

West Des Moines, Iowa, 50266, United States

Location

University of Michigan Medical School

Ann Arbor, Michigan, 48109, United States

Location

Spectrum Health Hospitals

Grand Rapids, Michigan, 49503, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

North Shore University Hospital, NY

Manhasset, New York, 11030, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

Krankenhaus Hietzing

Vienna, A-1130, Austria

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Québec, G1V4G5, Canada

Location

University Clinica Eppendorf

Hamburg, 20246, Germany

Location

Klinikum der Friedrich Schiller University

Jena, 07740, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease; Mitral Valve Insufficiency; Heart Failure; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: Edwards Lifesciences

Aya_Westbrook@edwards.com

949-250-2500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2009
• First Posted: March 2, 2009
• Study Start: August 1, 2007
• Primary Completion: March 6, 2024
• Study Completion: March 6, 2024
• Last Updated: May 14, 2025
• Results First Posted: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (10); AU (1); DE (2); CA (2)